November 24, 2020

The Niche

Knoepfler lab stem cell blog

FTC fires off many warnings to stem cell clinics on COVID-19

The FTC has sharply increased its oversight activities against stem cell and regenerative clinic firms. These new actions include quite a few warning letters. Here is the FTC database for COVID-19-related warning letters. Note that recently the FTC added a new, helpful option to view all of its warning letters here. It’s a good source of information.

BioXcellerator FTC
BioXcellerator, warned by FTC over stem cells for COVID-19, has many promotional videos. This is a screenshot from one.

FTC warns many stem cell & related firms

From USA Today, Brent Schrotenboer had this recent piece Stem cell companies sell hope with unproven medicine for COVID-19.

Some relevant regenerative-medicine-related warnings including: here, here, here, and then here for Brexo Bio.

At the time of Schrotenboer’s piece, the FTC had sent off 8 such warning letters (emphasis mine):

“The U.S. Food and Drug Administration, which oversees the safety and effectiveness of new medicine, has sent at least five of them letters involving questionable coronavirus-related claims. The Federal Trade Commission, charged with protecting consumers from misleading advertising, also has issued at least eight warning letters about unsubstantiated stem cell therapies for the virus.”

This wave of FTC activity is unprecedented in scope.

FTC seal
FTC seal.

I had previously covered 4 of the letters:

  • “Absolute Health Clinic. Based in Olympia, Washington, the business has promoted its products and services by representing, “Did you know our clinic [has] . . . treatments available to treat COVID-19? . . . available treatments include . . . high doses of Vitamin C and D through IV therapy, and Stem Cell Therapy.”
  • American Medical Aesthetics. According to marketing materials promoting the Los Angeles company’s products and services, people with COVID-19 have been “Cured with Ozone” and that treatments with “Mesenchymal Stem Cells” have been shown “to successfully treat the patient and reverse the illness.”
  • Center for Regenerative Cell Medicine. The FTC says the Scottsdale, Arizona, company has promoted its products and services by claiming on its website that “Mesenchymal stem cells are a viable option in new coronavirus infection treatment” and that stem cell therapy has “successfully treated” a COVID-19 patient.
  • Stemedix, Inc. “While experts are diligently working on vaccines and drugs, one surprising treatment has demonstrated efficacy for combatting [coronavirus]: stem cell therapy.” According to the FTC warning letters, that’s just one claim the Florida business has used to promote its products and services.”

Brexo Bio meets the FTC

One particular newer FTC letter Schrotenboer highlights is to Brexo Bio, which has some personnel with past ties to the San Diego clinic firm Stemgenex that filed for bankruptcy and is or was (not sure of its status) facing a class-action patient lawsuit.

Brexo Bio, BJ Retuya, Stem Cells COVID-19
Brexo Bio leader BJ Retuya.

From Schrotenboer:

“One FTC letter went to Brexo Bio on May 27. In it, the agency accused the company of unlawfully advertising that its services and products prevent or treat COVID-19. Those claims since have been removed from the website, which continues to offer access to other stem cell treatments in Mexico, where there are fewer legal restrictions for stem cell injections.

Brexo Bio has been run by BJ Retuya, a former sales director for another San Diego stem cell company, StemGenex, that filed for bankruptcy last year after the FDA accused it of illegally marketing an unapproved product to treat incurable diseases ranging from Alzheimer’s to rheumatoid arthritis”

BioXcellerator FTC letter

Another FTC warning went to BioXcellerator. The letter highlights how this firm markets unproven MSCs for COVID-19. It quotes specific problematic marketing claims including these:

“This year, humankind and science have been pushed and tested with the rise of COVID-19…. BioXcellerator is innovating in the world of Wharton jelly mesenchymal stem cells (WJ-MSC) and its applications, in this case, IMMUNOMODULATION…

Here is when science comes in with the stems, especially WJ-MSC, to do what is called immunomodulation. Tissue regeneration for the acute scar tissue, studies have shown that MSCs improved functional outcomes, demonstrating that IV infusions of MSCs is a safe and effective approach for treating patients with COVID-19 pneumonia, including elderly patients with severe cases of pneumonia. This treatment is particularly challenging as there is no vaccine or medication for this strain of the virus….”

Actually, as of yet there is no really solid evidence in my view that such MSCs can safely and effectively treat COVID-19. Looking up BioXcellerator on the web, I found it has some striking promotional videos on Vimeo. It seems like a common thread of many of the videos is mixed martial arts and pro wrestling, which is interesting. See screenshot from one such video above.

Additional FTC warnings to regenerative firms

Here are a few more examples of FTC warning letters in this space with excerpts from the agency:

  • “Anatara.  Also known as the San Francisco Stem Cell Treatment Center, the company promoted its treatments with the claim, “In addition to natural supplements, more advanced therapies such as stem cell therapy and exosome therapy may be beneficial for prevention COVID-19.”
  • “Colts Neck Stem Cell Center.  The clinic advertised its stem cell therapy with the claim, “Best way to protect yourself from COVID-19 is to boost your immune system . . . 1 Vial of Biogenix Stem Cells will modulate your immune system to ward off corona virus. 3 Vials will assist patients to survive with corona virus.”
  • “Integrative Medicine Center of Western Colorado.  In marketing materials titled “Coronavirus Disease 2019 (COVID-19) Treatments,” the office recommended its services and products, including stem cells, Vitamin C infusions, nebulized glutathione, black elderberry (“shown to have antiviral properties and is commonly used to treat colds or flu”) and AHCC (“derived from mushrooms and stimulates the immune system attack against viral infections”).

Will the FTC continue its stepped-up action in the regenerative space?

I hope the FTC continues its stepped up action in the regenerative sphere whether it is related to COVID-19 or not. However, it’s difficult to predict the FTC approach moving forward, especially if the pandemic space has fewer concerning regenerative clinic firms in it. The FTC really should be doing more on stem cell clinics even if they aren’t making COVID-19 claims, but we’ll see. The influx of politics into recent FDA decision making is not an encouraging sign.

On the other hand, a positive development is much closer coordination between the FDA and FTC as reflected in the FTC referencing the FDA in some of its warning letters and other indications of cooperation.

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